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Immuno-quantitative Trypsinogen Test (IRT) - Vietnam Registration 240001393/PCBB-HCM

Access comprehensive regulatory information for Immuno-quantitative Trypsinogen Test (IRT) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001393/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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240001393/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240001393/PCBB-HCM
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Device Details

Immuno-quantitative Trypsinogen Test (IRT)
VN: Bộ xét nghiệm định lượng trypsinogen miễn dịch (IRT)
Neonatal IRT Screening ELISA
Risk Class TTBYT Loại B

Registration Details

240001393/PCBB-HCM

000.00.19.H29-240607-0013

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Zentech SA

Technical Details

The quantitative determination of trypsinogen immunoreactivity (IRT) in dried blood spots from newborns on filter paper 903 or 226. Medical specialists use the test to screen for cystic fibrosis. The test is performed on a semi-automatic or automatic system.

Dates and Status

Jul 08, 2024